ARROW IPN917352Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10801902170641), received between Apr 1, 2021 and May 11, 2023 — classified as 2 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Separation Problem” (2 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 11, 2023Physical Resistance/Sticking; Physical Resistance/Sticking

  IT WAS REPORTED THAT THE PARAMEDIC ATTEMPTED TO ESTABLISH A HUMERAL IO. THE PARAMEDIC FELT A POP, BUT WAS UNABLE TO UNTHREAD THE STYLET FROM THE HOLLOW NEEDLE. HE THEN ATTEMPTED TO ESTABLISH A TIBIAL IO WITH A DIFFERENT NEEDLE, BUT AGAIN WAS UNABLE TO UNTHREAD THE STYLET. THE AMBULANCE PROVIDER ARRIVED ON SCENE AND USED THEIR EZ-IO SYSTEM, WHICH WAS ABLE TO ESTABLISH AN IO ON THE OTHER TIBIA WITH NO ISSUES. NO PATIENT HARM OR INJURIES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16912246 ↗
• InjuryNov 30, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDWATCH (B)(4). PATIENT ARRIVED AS TRAUMA ACTIVATION ON (B)(6) 2022 FROM THE SCENE OF A MOTORCYCLE CRASH. PATIENT WAS TRANSPORTED BY LIFENET MEDEVAC WHO PLACED INTRAOSSEOUS CATHETER IN RIGHT HUMERUS AT 1540 PTA IN ED FOR ACCESS. AN A-LINE AND CENTRAL LINE WERE PLACED IN ED PRIOR TO OR. NO DOCUMENTATION OF INTRAOSSEOUS CATHETER REMOVAL. ON (B)(6) 2022 PATIENT COMPLAINED OF PAIN IN RIGHT SHOULDER WITH OCCUPATIONAL THERAPY. X-RAYS ORDERED BY ORTHO RESIDENT WITH NOTE OF RETAINED FOREIGN BODY, IO NEEDLE. NO DOCUMENTATION FOUND OF WHEN IO WAS REMOVED. TYPICALLY, THESE ARE REMOVED ONCE CENTRAL ACCESS OBTAINED. PATIENT SENT TO OR ON (B)(6) 2022 TO REMOVE RETAINED CATHETER NEEDLE, WITH NO FURTHER COMPLICATIONS.

  Patient problems: Foreign Body In Patient

  MAUDE report 15890626 ↗
• InjuryJul 29, 2021Break; Break

  DURING REMOVAL OF I/O THERE WAS MORE TRAUMA THAN ANTICIPATED. ITEM WAS USED IN THE FIELD BY THE EMS PARAMEDIC. THEY REPLENISHED THEIR STOCK FROM BURLINGTON ED. THIS IS WHERE THE DEFECTIVE ITEM WAS PULLED FROM. THE TEAM LOST THE PACKAGING. THE BROKEN PRODUCT WAS KEPT PER THE NOTES. THE YELLOW HUB BECAME DETACHED FROM THE NEEDLE AND REQUIRED UNNECESSARY SURGERY FOR REMOVAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12245041 ↗
• MalfunctionJun 17, 2021Separation Problem; Separation Problem

  RN WENT TO REMOVE IO FROM LEFT HUMERUS. WHEN TWISTING OFF THE EXTENSION TUBING, LUERLOCK, FROM THE PLASTIC HEAD PORTION OF THE NEEDLE, THE PLASTIC PORTION CAME OFF. THE NEEDLE APPEARS TO REMAIN EMBEDDED WITHIN THE PATIENT'S LEFT HUMERUS. IN REVIEWING THE PSLS, THE NEEDLE WAS RESECTED OUT AT THE BEDSIDE WITHOUT COMPLICATION. I THINK I REMEMBER THE NURSE TELLING ME THAT THEY USED A NEEDLE DRIVER TO PULL IT OUT. THE EVENT OCCURRED BACK IN OCTOBER AND THE PATIENT'S CURRENT CONDITION IS UNKNOWN. THEY HAVE SINCE BEEN DISCHARGED FROM THE HOSPITAL. THE NEEDLE WAS REMOVED AT THE BEDSIDE BY A PHYSICIAN. AS PER THE ICU PROGRESS NOTE ON OCTOBER 27 THE BROKEN NEEDLE OF HIS IO NEEDLE WAS RESECTED OUT. IT DOES NOT ELABORATE IN WHAT MANNER THIS WAS DONE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12019202 ↗
• MalfunctionJun 17, 2021Separation Problem; Separation Problem

  FACILITY IS UNABLE TO IDENTIFY THE LOT NUMBER OF THE DEVICE. RN ATTEMPTED TO REMOVE PATIENT'S IO NEEDLE GAUZE 20. THE YELLOW HANDLE/GRIP BECAME SEPARATED FROM THE NEEDLE, SO THE METAL PIECE WAS STICKING OUT. RN TRIED TO REMOVE NEEDLE WITH METAL CLAMPS AVAILABLE ON THE UNIT BUT WAS UNSUCCESSFUL. WIRE TWISTER FROM OR WAS FINALLY USED AND RN WAS ABLE TO REMOVE THE NEEDLE OUT. THE PATIENT WAS (B)(6) YEARS OLD WITH A HISTORY OF ATRIAL FIBRILLATION ON ELIQUIS, HF,HTN, HLD, DM. THE CAUSE OF THE PATIENT'S DEATH WAS ISCHEMIC STROKE, BILATERAL CAROTID OCCLUSION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12019096 ↗
• MalfunctionApr 1, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  I ATTEMPTED TO REMOVE IO NEEDLE AFTER TLC PLACEMENT CONFIRMED. UNABLE TO REMOVE DEVICE DIFFICULT TO TURN DEVICE WITH SYRINGE. PATIENT COMPLAINED OF SEVERE PAIN WHEN I TRIED TO REMOVE DEVICE. I TRIED TURNING DEVICE WITH SYRINGE AND ATTEMPTED REMOVE WITH HEMOSTATS. I NOTIFIED TEAM OF DIFFICULTY ASKED FOR PREMEDICATION. ACTION: MEDICATED WITH FENTANYL AND RN ATTEMPTED TO REMOVE DEVICE. YELLOW PLASTIC CAP BROKE, LEAVING IO NEEDLE IN PATIENT'S ARM. X/R OF ARM TAKEN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11605423 ↗